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Government fast-tracks approvals for vital drugs

Sandoz injectable products at a pharmacy Thursday, March 8, 2012 in Quebec City. Sandoz Canada, a leading maker of injectable drugs, announced it has suspended or discontinued production of some drugs, prompting fears of a shortage of critical medications.

Jacques Boissinot/The Canadian Press/Jacques Boissinot/The Canadian Press

The federal government is working to fast-track approvals of alternative supplies of key medications as hospitals across the country cope with an ongoing shortage that is jeopardizing surgeries.

Drugs from other countries that once would have taken nearly a year to get the clearance for use in Canada are now being approved in a matter of weeks, and the government says health officials are working "around the clock" to provide access to alternate sources.

"We are fast-tracking approvals for products including those produced abroad and approved by trusted counterparts," said Health Minister Leona Aglukkaq. "We are working with our international partners to share safety data to help speed up our review."

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Libby Davies, the New Democrat health critic, agrees that the main objective should be to find substitutes for the medicines that are in temporary short supply amid ongoing problems at the factory that manufactures about 90 per cent of Canada's generic injectable drugs.

At the same time, Ms. Davies said Thursday, the government must start living up to its commitment to honour an NDP motion that says drug manufacturers will be required to promptly report any planned disruption or discontinuation in production to Health Canada as well as the provinces and territories.

The motion, which was passed unanimously in the House of Commons this week, also calls for a national strategy to anticipate, identify and manage shortages of essential medications. But getting a reporting system running is critical in the short term, Ms. Davies said, as is making "it clear that it's required, it's not a voluntary thing."

Ms. Davies said her party has not specified whether that has to be done through regulations or legislation. "We are saying that if it's going to move beyond voluntary then it's got to be somehow written down, enforced," she said. "The government has got to respond to that and make it clear how they will make that requirement happen."

It is not yet certain, however, whether the government will be moving ahead with legislation or regulation to enforce the drug companies to comply. The NDP motion was non-binding.

Ms. Aglukkaq said, even when she first introduced the voluntary system last fall, that the government is open to doing whatever is required to get the information into people's hands, up to and including regulation. But, for now, she may allow the voluntary system to stand.

"I want to make sure doctors and patients are aware of potential drug shortages, so they can make informed decisions about treatment," the minister said Thursday. "Regulation is not a silver bullet, because when a sole-source drug provider has a fire at their plant, regulations can't predict that. We're focusing on dealing with the current shortage, and then we'll look more closely at what approach serves Canadians best."

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Drug shortages have been a problem for doctors and their patients since long before the fire at the Sandoz Canada plant in Boucherville, Que., temporarily halted production. The blaze followed a letter sent to Sandoz from the U.S. Food and Drug Administration raising concerns about the level of sanitation at the factory, which affected only drugs exported to the U.S.

Jeff Morrison, a spokesman for the Canadian Pharmacists Association, said his group has been working since the fall with drug manufacturers and other health providers to create a voluntary reporting system. "It remains our preference to continue down that path," he said, "because we have made some progress."

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About the Author
Parliamentary reporter

Gloria Galloway has been a journalist for almost 30 years. She worked at the Windsor Star, the Hamilton Spectator, the National Post, the Canadian Press and a number of small newspapers before being hired by The Globe and Mail as deputy national editor in 2001. Gloria returned to reporting two years later and joined the Ottawa bureau in 2004. More

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